The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01961180

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Cipralex Drug: Placebo	Phase 4

Detailed Description

We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes.

Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.

We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Cipralex in Polycystic Ovary Syndrome

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: active comparator Drug: Cipralex	Drug: Cipralex the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects. Other Names: Escitalopram
Placebo Comparator: placebo comparator Drug: Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: active comparator

Drug: Cipralex

Drug: Cipralex

the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.

Other Names:

Escitalopram

Placebo Comparator: placebo comparator

Drug: Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Quality of Life [14 weeks]
Measured by questionaires

Secondary Outcome Measures

Level of cortisone in 24 hour urine sample [June 2013 to October 2015]
Cortisone and cortisone metabolites, measured by 24 hour urine sample.

Other Outcome Measures

Glucose metabolism [June 2013 to October 2015]
measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI >25 and <50
Age < 50
PCOS

Exclusion Criteria:

Epilepsia
use of metformin or oral anticonceptives
pregnancy/breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endocrinology, Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator: Marianne MD Andersen, sponsor, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marianne Andersen, Professor, chief physisian, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT01961180

Other Study ID Numbers:

24638418

First Posted:

Oct 11, 2013

Last Update Posted:

May 9, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Marianne Andersen, Professor, chief physisian, Odense University Hospital

Quality of Life

Adrenal hyper activity

Glucose metabolism

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Citalopram

Study Results

No Results Posted as of May 9, 2016